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| Name | Class |
|---|---|
| Unilever R&D | INDUSTRY |
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This study is testing the effectiveness of a dietary intervention by means of measuring the change in RQ upon a hyperinsulinemic euglycemic clamp challenge and by means of measuring the kinetic responses of multiple PF markers (including RQ) to an acute mixed meal challenge before and after a 6-week dietary intervention. The challenges will be applied to investigate whether the kinetic response is a better measure for health and wellbeing when compared to fasting (baseline) levels. In addition, several measures that reflect perceivable benefits like mood, quality of life, sleep quality, cognitive and physical performance will be assessed in a first exploratory attempt to link (changes in) PF to consumer perceivable benefits.
Subjects will be randomly allocated to a low glycemic load diet or a 'Western' diet for 6 weeks. Before and after the intervention several measurements will take place. The low glycemic load diet will be high in polyphenols, protein, vegetables, pulses, fibres and nuts, and low in glycemic carbohydrates. All these dietary factors have been shown to improve glycemic control and/or to reduce metabolic syndrome risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low glycaemic load diet | Experimental | Subjects will be following a low glycaemic load diet, typically high in polyphenols, proteins, vegetables, pulses, fibres and nuts, and low in glycemic carbohydrates, for six continuous weeks. |
|
| Western diet | Experimental | Subjects will be following a western diet, typically high in saturated fat, refined sugars and salt, and low in fruit and vegetables and fibers, for six continuous weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low glycaemic load diet | Other | Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a low glycemic load diet for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic flexibility, as measured by delta RQ (change in RQ) upon a hyperinsulinemic euglycemic clamp | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic flexibility, as measured by delta RQ (change in RQ) upon a mixed meal challenge | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention | |
| Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, upon a mixed meal challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Functional markers of cognitive performance, as measured by attention, memory and executive function | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention | |
| Functional markers of physical performance, as measured by the timed up-and-go test (TUGT), the 6-minute walk test, handgrip and muscle strength tests |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Schrauwen, Professor | Maastricht University Medical Center | Principal Investigator |
| Ronald Mensink, Professor | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | 6200 MD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33096554 | Derived | Fechner E, Bilet L, Peters HPF, Schrauwen P, Mensink RP. A Whole-Diet Approach Affects Not Only Fasting but Also Postprandial Cardiometabolic Risk Markers in Overweight and Obese Adults: A Randomized Controlled Trial. J Nutr. 2020 Nov 19;150(11):2942-2949. doi: 10.1093/jn/nxaa252. | |
| 31899037 | Derived | Fechner E, Bilet L, Peters HPF, Hiemstra H, Jacobs DM, Op 't Eyndt C, Kornips E, Mensink RP, Schrauwen P. Effects of a whole diet approach on metabolic flexibility, insulin sensitivity and postprandial glucose responses in overweight and obese adults - A randomized controlled trial. Clin Nutr. 2020 Sep;39(9):2734-2742. doi: 10.1016/j.clnu.2019.12.010. Epub 2019 Dec 17. |
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| ID | Term |
|---|---|
| D066273 | Diet, Western |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Western diet | Other | Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a 'Western' diet for 6 weeks. |
|
| Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Diet-induced changes in the Kinetic responses vs. the baseline values of RQ and various phenotypic flexibility parameters such as lipids, glucose, inflammatory markers and more | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Phenotypic flexibility markers, as measured by various blood parameters such as lipids, glucose, inflammatory markers and more, in the fasted state | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Insulin sensitivity, as measured by a hyperinsulinemic euglycemic clamp | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Sleep quality, as assessed with the10-item Pittsburgh Sleep Quality Index | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Mood, as assessed by the Affect grid | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Quality of life, as assessed by a 32-item questionnaire, including social, spiritual, emotional, cognitive, physical, activities of daily living and integrated quality of life | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| Body composition, as measured by the deuterium water method | Within 5 days before the start of the 6 week dietary intervention and again in the 6th week of the dietary intervention |
| 36-hour blood pressure, as measured by the continuous blood pressure device mobil-o-graph | 36 hours within 5 days before the 6 week dietary intervention and again 36 hours in the 6th week of the dietary intervention |
| 36-hour glycaemic response, as measured by the continuous blood glucose device ipro2 (Medtronic) | 36 hours within 5 days before the 6 week dietary intervention and again 36 hours in the 6th week of the dietary intervention |